Clinical Development Success Rates for Innovative Drugs in China

Background and Objective: In Mainland China, there exists rapid economic development, a huge demand for medication and remarkable progress in the development of innovative drugs. Thus, it is of great practical significance to evaluate the efficiency of drug innovation in China by measuring clinical development success rates. Materials and Methods: This study retrospectively analyzed the status of investigational new drug (IND) submissions for innovative drugs filed in mainland China between January 1, 2003 and May 31, 2019, calculating the phase transition probability and approval probability of 1,076 innovative drugs from 506 applicants. Results: This study found the overall approval probability of innovative drugs is 21%. The phase transition probability and approval probability vary by drug class, therapeutic class and applicant type. By drug class, the approval probability of therapeutic biologics (29%) is higher than that of preventive biologics (20%) and chemical drugs (19%). By therapeutic class, the approval probability of gastrointestinal and metabolic drugs (28%) is higher than that of antineoplastic and immunologic agents (26%) and systemic anti-infective (21%). The approval probability of drugs produced by applicants from economically-developed Eastern China (24%) and large-scale enterprises (30%) are leading in the overall industry. Conclusion: This study discovered an increasing number of IND submissions and revealed recent innovations concentrated on therapeutic biologics and medications for cancer and immunological disorders. It also suggested that China will play a significant role in future global pharmaceutical innovation with sustained policy optimization and expansion of the domestic pharmaceutical industry.